Devices, system, and methods for guiding an operative tool into an interior body region

ABSTRACT

A guide device establishes a guide passage through a guide tube, through which an operative tool can be deployed into an interior body region for use. A steering assembly, in use, deflects or bends the distal end region of the guide tube, so that the operative tool can be placed in a desired orientation with respect to tissue. The steering assembly is desirable configured for single handed operation by the clinician. The steering assembly is also desirably configured to provide a mechanical advantage sufficient to translate relatively small increments of clinician control into relatively larger increments of guide tube deflection. In one arrangement, the steering assembly includes a rack and pinion linkage system. In another arrangement, the steering assembly includes a pivoting lever system.

RELATED APPLICATIONS

This application is a continuation of co-pending U.S. patent applicationSer. No. 11/254,619, filed Oct. 20, 2005, now allowed, which is acontinuation-in-part of U.S. patent application Ser. No. 11/166,411,filed Jun. 24, 2005, (now U.S. Pat. No. 8,092,519), entitled“Endovascular Aneurysm Repair System,” which is a divisional of U.S.patent application Ser. No. 10/271,334, filed Oct. 15, 2002 (now U.S.Pat. No. 6,960,217), which claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/333,937, filed Nov. 28, 2001, and entitled“Endovascular Aneurysm Repair System,” which are each incorporatedherein by reference. This application is also a continuation-in-part ofU.S. patent application Ser. No. 10/307,226, filed Nov. 29, 2002, (nowU.S. Pat. No. 8,075,570), and entitled “Intraluminal ProsthesisAttachment Systems and Methods” and a continuation-in-part of U.S.patent application Ser. No. 10/669,881, filed Sep. 24, 2003, (now U.S.Pat. No. 7,491,232), and entitled “Catheter-Based Fastener ImplantationApparatus and Methods with Implantation Apparatus and Methods withImplantation Force Resolution,” which are each incorporated herein byreference.

FIELD OF THE INVENTION

This invention relates generally to devices, systems, and methods thatguide operative tools within a vessel or hollow body organ.

BACKGROUND OF THE INVENTION

In the field of steerable guide systems, there is a need to translate acomfortable rotational manipulation by a physician into an effectivedistal deflection. There is also a need for a guide system that wouldprovide a mechanical advantage such that a minimal manipulation by aphysician would provide a sufficient distal deflection.

SUMMARY OF THE INVENTION

The invention provides improved devices, systems, and methods forguiding an operative tool for use within an interior tissue region.

According to one aspect of the invention, a guide device comprises aguide tube that establishes a guide passage through which an operativetool can be deployed into an interior body region for use. The deviceincludes a steering assembly that, in use, deflects or bends the distalend region of the guide tube, so that the operative tool can be placedin a desired orientation with respect to tissue.

The steering assembly is desirable configured for single handedoperation by the clinician. The steering assembly is also desirablyconfigured to provide a mechanical advantage sufficient to translaterelatively small increments of clinician control into relatively largerincrements of guide tube deflection.

In one embodiment, the steering assembly includes a rack and pinionlinkage system that translates rotation of an actuator into linearmovement of a rack into rotation of a gear train, to apply a tensionforce to a deflecting component coupled to the distal end region of theguide tube.

In another embodiment, the steering assembly includes a pivoting leversystem that translates rotation of an actuator into linear movement of aslider into pivotal movement of a lever arm, to apply a tension force toa deflecting component coupled to the distal end region of the guidetube.

In both embodiments, the tension applied to the deflecting componentbends or deflects the distal end region of the guide tube.

In one embodiment, the operative tool applies one or more fasteners totissue. The steerable guide device makes it possible to accuratelyorient and maintain the fastening tool with respect to tissue, withoutthe need to place a steering mechanism on-board the fastening tool orwithout the need to equip the fastening tool with a guide wire lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plane view of a steerable guide device in its straightened,undeflected position.

FIG. 1A is a plan view of a dilator for use with the steerable guidedevice of FIG. 1.

FIG. 2 is a plane view of the steerable guide device shown in FIG. 1 inassociation with an operative tool.

FIG. 3 is a plane view of the steerable guide system shown in FIG. 1,showing a clinician's hand rotating an actuator knob to operate anassociated steering assembly to cause bending or deflection of thedistal end region of the device.

FIG. 4 is a plane view of the steerable guide device shown in FIG. 3 inassociation with on operative tool.

FIGS. 5A, 5B, and 5C are plane views of the distal end region of thedevice shown in FIG. 4, showing the presence of a radiopaque marker thatis shaped to provide a different visual image depending upon itsorientation, respectively, anteriorly (FIG. 5A), posteriorly (FIG. 5B),or laterally (FIG. 5C).

FIG. 6A is an interior section view of the distal end region, of thedevice shown in FIG. 3, taken generally along line 6A-6A of FIG. 6B.

FIG. 6B is a perspective end view, partially broken away, of the distalend region of the device shown in section in FIG. 6A.

FIG. 6C is a perspective end view, partially broken away, of analternative embodiment of the distal end region of the device shown inFIG. 6B.

FIG. 6D is a perspective end view, partially broken away, of the distalend region of an alternative embodiment of the device shown in FIG. 6A,and showing multiple control lumens to direct the distal end region inmore than one direction.

FIG. 6E is a plane view of the distal end region of the alternativeembodiment shown in FIG. 6D, and showing the distal end region havingtwo 90 degree deflections.

FIG. 7 is a plane view, partially diagrammatic, showing the attachmentof the guide tube of the device to the handle of the device, and theformation of an interior passage through the handle and guide tube toreceive an operative tool.

FIG. 8 is a plane side view, of the device shown in FIG. 1, with thehandle broken away and in section to show the components of the steeringassembly within the handle, the operation of which bends or deflects thedistal end region in the manner shown in FIG. 3.

FIG. 9 is an exploded view, with parts partially broken away and insection, showing the main components of the device, including thecomponents of the steering assembly shown in FIG. 8.

FIG. 10 is a section view taken generally along line 10-10 in FIG. 8.

FIG. 11 is a plane side view, of the device shown in FIG. 3, with thehandle broken away and in section to show the operation of the steeringassembly within the handle to bends or deflects the distal end region ofthe device.

FIG. 12 is side plane view of a steerable guide device, with the handlebroken away and in section, showing an alternative steering assembly inits neutral position, in which the distal end region of the guide tubeis straight and undeflected.

FIG. 13 is side plane view of a steerable guide device shown in FIG. 12,with the handle broken away and in section, showing the operation of thealternative steering assembly to bend or deflect the distal end regionof the guide tube.

FIG. 14 is a side view of the steerable guide device and associatedoperative tool, as also generally shown in FIG. 4, with the operativetool shown to be an endovascular fastener oriented by the guide deviceor the application of a fastener to a prosthesis deployed in a tissueregion.

DESCRIPTION OF PREFERRED EMBODIMENTS

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structures. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

I. Overview

FIG. 1 shows a steerable guide device 10. The steerable guide device 10comprises a flexible guide tube 12 carried by a handle 14. The illegibleguide tube 12 may be constructed, for example, by extrusion usingstandard flexible, medical grade plastic materials. Further details ofthe guide tube 12 will be described later.

The handle 14 may be constructed, for example, from molded plastic. Thehandle 14 is sized to be conveniently held by a clinician, to introducethe guide tube 12 into an interior body region that has been targetedfor treatment.

As used in this disclosure, the term “proximal” refers to the aspect ofthe device that is, in use, held by the clinician, while the term“distal” to the aspect of the device that is, in use, positioned in ortoward the body.

The purpose of the guide device 10 is to establish an open path throughwhich an operative tool 16 can be deployed for use. For this purpose(see FIG. 2), the guide device 10 includes an interior guide passage 18.The guide passage 18 extends through an interior portion of the handle14 continuously into and through the guide tube 12. Entrance into theguide passage 18 is provided by a proximal opening 20 formed in thehandle 14. The guide passage 18 terminates at an opening 22 at thedistal end of this guide tube 12. Further details of the configurationof the guide passage 18 will be described later.

As FIG. 2 shows, the guide passage 18 is sized and configured so that,in use, the operative tool 16 can be inserted through the proximalopening 20 and advanced through the passage 18 outwardly beyond thedistal opening 22. Use of the guide device 10 in this manner facilitatesthe deployment and positioning of the operative tool 16 that, byconstruction, may be less flexible and harder to manipulate than theguide tube 12 itself.

The guide tube 12, while flexible, preferable has a plastic memory orbias that normally orients the distal end region of the guide tube 12 inan essentially straight configuration, as shown in FIG. 1. To enablegreater control of the orientation of the distal end region of the guidetube 10, the guide device 10 includes a steering assembly 24. Inoperation, the steering assembly 24 deflects the distal end region ofguide tube 12 out of its essentially straight configuration and into abent or deflected configuration, as shown in FIG. 3.

In its essentially straight configuration, the guide tube 12 is welloriented for deployment into an interior body region, e.g., through anintra-vascular or cannulated access path. During such deployment, theguide tube 12 may be passed over a conventional guide wire, which can beinserted through the interior passage 18. Or alternatively, the guidetuba 12 may be used with a dilator 60 (see FIG. 1A) which may beinserted through the interior guide passage 18. The dilator 60 featuresa tapered nosecone 62 on its distal end, a Luer type connector 64 on itsproximal end, and a shaft 66 coupling the nosecone 62 to the Luerconnector 64. The dilator 60 desirably includes a guide wire lumen 68extending throughout the length of the dilator. In use, the taperednosecone 62 extends past the distal tip or opening 22 of the steerableguide catheter 10 to facilitate access to the intra-vascular orcannulated access path and provide improved tracking onto the guidewire.

Upon deployment of the guide tube 12 to a desired body region (andwithdrawal of the guide wire and dilator 60, if used), a clinician canoperate the steering assembly 24 to deflect the distal end region of theguide tube 12 in its bent or deflected condition. A radiopaque marker M(see FIG. 3) can be placed on the distal end region to permitfluoroscopic visualization of the orientation of the deflected endregion. In its bent or deflected configuration, the distal passage end22 can be oriented in a desired relationship with a targeted tissuesurface in the body region.

Desirably—as FIGS. 5A, 5B, and 5C show—the radiopaque marker M forms apartial ring (i.e., C-shaped) or comparable shape that changes dependingupon orientation, so that the radiopaque image is visually distinct whenobserved in different orientations, e.g., presenting an upward U-shapewhen in an anterior orientation (FIG. 5A); or a downward U or “little-N”shape when in a posterior orientation (FIG. 5B); or an edge-on shapewhen in a lateral orientation (FIG. 5C). It should be appreciated thatmultiple radiopaque markers can also be used to provide an image whichis visually distinct when observed in different orientations.

Desirably (as FIG. 3 shows), the guide tube 12 is placed into its bentor deflected configuration before passage of the operative tool 16through the passage 18. Once in its bent or deflected configuration, asFIG. 4 shows, the operative tool 16 can be advanced through the passage18 and guided by the bent configuration into the desired relationshipwith the tissue surface for use.

The steering assembly 24 holds the distal end of the guide tube 12 inits deflected condition, thereby maintaining the operative tool 16 inits desired relationship during use. The steerable guide tube 12obviates the need to equip the operative tool 16 with an on-boardsteering mechanism or a guide wire lumen.

As FIGS. 3 and 4 show, the steering assembly 24 is desirable configuredfor single handed operation by the clinician. The steering assembly 24is also desirably configured to provide a mechanical advantagesufficient to translate relatively small increments of clinician controlinto relatively larger increments of guide tube deflection.

As will be described in greater detail later, and as FIG. 3 generallyshows, the steering assembly 24 includes an actuator 26 that can bemanipulated by the clinician. The actuator 26 is coupled through alinkage system 28 to a deflecting component 30, which is coupled to thedistal end region of the guide tube 12.

In general operation, manual force applied by the clinician to theactuator 26 is translated by the linkage system 28 into a pulling forceor tension exerted on the deflecting component 30, which deflects orbends the distal end region of the guide tube 12. The linkage system 30is desirably configured with a mechanical advantage that amplifiesrelatively small increments of movement of the actuator 26 intorelatively larger increments of movement of the deflecting component 30.

Further details of particular embodiments of the guide tube 12 and thesteering assembly 24 will now be described.

A. Components of the Guide Tube

Referring to FIGS. 6A and 6B, in the illustrated embodiment, the guidetube 12 comprises a main lumen 32, which constitutes a portion of theinterior passage 18, already described. The guide tube 12 also includesa control lumen 34. The deflection component 30, previously described,extends through the control lumen 34.

The illustrated embodiment shows one control lumen 34 and one deflectioncomponent 30. It should be appreciated that multiple control lumens (anddeflection components) can be provided, if desired. As can be seen inFIGS. 6D and 6E, multiple control lumens would provide the ability todirect the flexible guide tube 12, (e.g., the distal end region) of thesteerable guide 10 in more than one direction. For example, two controllumens 34, 34′ oriented 180 degrees apart (along with two deflectioncomponents 30, 30′) would allow the distal end region to be deflected 90degrees in two directions within one plane. This feature would allow foradditional steering control to accurately position the distal opening 22at the targeted tissue site.

In the illustrated embodiment, the control lumen 34 is also shown toextend outside the main lumen 32. It should be appreciated that thecontrol lumen 34 can extend inside the main lumen 32, or the main lumen32 and the control lumen 34 can be formed as a composite.

Both the main lumen 32 and the control lumen 34 desirably include aliner 36. Each liner 36 preferably comprises a material with a lowcoefficient of friction, such as PTFE, although other materials havingcomparable mechanical properties can be used. The presence of the liner36 in the main lumen reduces friction to ease the passage of theoperative device 18 through the main lumen 32. The presence of the liner36 in the control lumen 34 reduces friction and this moderates thepulling force or tension necessary to manipulate the deflectingcomponent 30.

The guide tube 12 also desirably includes a reinforcement sheath 38. Thereinforcement sheath 38 envelopes both the main lumen 32 and controllumen 34. The reinforcement sheath 38 can have multiple shapeconfigurations, can be made of multiple materials, and can be arrangedin multiple patterns. Patterns can range from a simple coil to a complexbraid arrangement. The pattern can be uniform or can vary along thelength of the catheter tube 12. In the illustrated embodiment, thereinforcement sheath 38 is in the form of a braid made of round wiremade, e.g., from stainless steel, titanium, cobalt alloys, polymers, andnatural fibers.

The guide tube 12 also desirably includes a tip reinforcing element(s)40. The reinforcing element 40 is disposed at or near the distal opening22 of the passage 18, and serves to resist collapse or distortion of themain lumen 32 during deflection as a result of pulling on the deflectingcomponent 30.

In a desired embodiment, (see FIG. 6B), the tip reinforcing element 40comprises a metallic ring, such as a uniform ring, but other shapes andmaterials are also contemplated. As seen in FIGS. 6A and 6B, the tipreinforcing element 40 is shown disposed over the reinforcement sheath38. Alternatively, the tip reinforcing element 40 and the reinforcementsheath 38 can comprise a composite structure.

In the desired embodiment, the deflecting component 30 makes acontinuous loop completely around the tip reinforcing element 40 andreturns back through the control lumen 34 into the handle 14, where itis coupled to the linkage system 28, as will be described in greaterdetail later. In an alternative embodiment (see FIG. 6C), the deflectingcomponent 30 loops around only a portion of a reinforcing element 41. Asshown, the reinforcing element 41 comprises more than one ring (i.e.,two or more individual rings) coupled together with at least onecoupling element 43. In this configuration, the deflecting component 30may be looped around one or more coupling element(s) 43.

The guide tube 12 also desirably includes a cover 42. The cover 42envelopes all of the internal structures heretofore described, forming acomposite structure. The cover 42 can be made of different types ofmaterial or of a uniform material with different physicalcharacteristics throughout the length of the guide tube 12. The cover 42can be of uniform thickness, or the thickness can vary along the lengthof the guide tube 12. In a preferred embodiment, the cover is made of apolymer material of differing hardness. The softest portion is locatedat the distal portion of the guide tube 12 (near the opening 22) and thestiffer portion is located at the proximal portion of the guide tube 12(within the handle 14). The cover 42 can also include a material withinthe polymer which allows the cover 42 to be radiopaque or a materialthat reduces friction.

The tip reinforcing element 40, 41 and/or reinforcement sheath 38 canalso be used as radiopaque markers. Alternatively, or in combination,one or more radiopaque markers M can be attached to the distal end ofthe catheter assembly 12. The use of radiopaque materials makes itpossible to gauge the deflected orientation of the guide tube 12. Agiven radiopaque marker can made from platinum. Still, other materials(and different shapes) can be used.

As FIG. 7 shows, the guide tube 12 extends into the distal and of thehandle 14. A transition shaft 44 is connected at one end to the proximalend of the guide tube 12 (where the cover 42 is stiffer) and at theother end to a sealing element 46 that occupies the proximal-most regionof the handle 14. The sealing element 46 includes an interior lumen 48that comprises an extension of the interior passage 18, and alsoincludes the proximal opening 20. The transition shaft 44 also includesan interior lumen 50 that also forms an extension of the interiorpassage 18, linking the main lumen 32 of the guide tube 12 incommunication with the proximal opening 20. The transition shaft 44 canbe an integrated component of the guide tube 12.

The sealing element 46 desirably includes an in-line hemostatic valveassembly 52 at or near the proximal opening 20 of the passage 18. Thevalve assembly 52 prevents blood or fluid loss by sealing the proximalopening 20 when an operative tool 16 is within the passage 18, as wellas when no operative tool 16 is present in the passage 18.

The valve assembly 52 desirably includes a main seal component 54 and alip seal component 56, which can comprise separate or integratedcomponents. The main seal component 54 seals the proximal opening 20 inthe absence of an operative tool 16 in the passage 18. The lip sealcomponent 56 seals upon insertion of the operative tool 16 through theproximal opening 20 into the passage 18.

An infusion valve 58 can also be coupled to the passage 18 through thesealing element 46. In this way, fluid can be conveyed through thepassage 18 into the interior body region, e.g., to flush materials fromthe passage 18 during use.

As described, the guide tube 12 is secured to the handle 14 and does notrotate relative to the handle 14. To rotate the guide tube 12, theclinician must rotate the handle 14.

B. Components of the Steering Assembly

1. The Actuator

It should be appreciated that the actuator 26 of the steering assembly24 can take many forms, such as a sliding lever or a pistol grip. Theactuator 26 can be located at many locations on the handle 14, such asthe proximal end, the distal end, or the mid-portion. In the embodimentshown in FIGS. 1 to 4, the actuator 26 takes the form of a fluted knobthat is rotationally attached to the distal end of the handle 14. Theknob 26 is positioned so that it can be rotated by the thumb of theclinician's hand that holds the handle 14. As shown in FIG. 3, thehandle 14 may be held in the palm of the hand while the knob 26 ismanipulated by the thumb.

In the illustrated arrangement (best shown in FIGS. 8 and 9), the knob26 includes front and rear thrust bearing surfaces 132 and 134. Thesethrust bearing surfaces can be integral to the knob component or theycan be separate components which are added to the knob 26 to make acomplete assembly. Front and rear journals 136 and 138 on the handle 14support the thrust bearing surfaces 132 and 134, so that the knob 26 canbe easily rotated relative to the distal end of the handle 14 bymovement of the thumb.

2. The Linkage System

a. Rack and Pinion Gear Assembly

In the illustrated arrangement, the linkage system 28 translatesrotational movement of the actuator knob 26 into a linear forcedirection. To affect this translation (see FIGS. 8 and 9), the linkagesystem 28 includes a female threaded shaft 140 formed within the knob26, which rotates in common with the knob 26, and a threaded malecomponent 146 that is coupled to a slider 142, which is mounted forlinear movement in a channel 144 within the handle 14. It should beappreciated that the thread placement on both of these elements could bereversed. The threads can take any form and/or type, and can beself-locking or non-locking. In a preferred arrangement, the threads onthe female threaded shaft 140 and the male threaded component 146 arelocking.

The slider 142 is restrained by the channel 144 from twisting orrotating. Coupled to the slider 142, which is kept from twisting orrotating within the channel 144, the threaded component 146 is likewisekept from rotation.

The threaded male component 146 extend from the slider 142 in thedirection of the knob 26. The male threads on the component 146 areconfigured to thread into the female threads of the shaft 140 inresponse to rotation of knob 26. Rotation of the knob 26 progressivelymoves the threaded component 146 within the shaft 140. The slider 146follows, moving in a linear direction within the channel 144 fore(toward the distal end of the handle 14) or aft (toward the proximal endof the handle 14), depending upon the direction the knob 26 is rotated.Aft linear movement of the slider 142 within the channel 144 is haltedby a proximal stop 148. This position (i.e., when the slider 142 restsin abutment against the stop 148) (as shown in FIG. 8) will be called inshorthand a “neutral position,” because, in this position, the linkagesystem 28 is configured to apply no force upon the deflecting component30.

When in the neutral position (as shown in FIG. 8), the male component146 extends from the slider 142 a distance sufficient to thread aportion of the male component 146 within a portion of female threads ofthe shaft 140. When in the neutral position, rotation of the knob 26 ina single predetermined direction (in the illustrated embodiment,clockwise from the clinician's view point) (see FIG. 11) advances thecomponent 146 along the shaft 140 and draws the slider 142 in a linearforward direction within the channel 144 (i.e., toward the knob 26). Itshould be appreciated that the direction for activation could bereversed (i.e., rotating the knob 26 advances the slider 142 in a lineardirection away from the knob 26).

The linkage system 28 is configured to translate this linear forwardmovement of the slider 142 into a tension or pulling force on thedeflecting component 30. To affect this translation, the linkage system28 includes a rack and pinion gear system. More particularly (see FIGS.8 and 9), a rack 150 is coupled to slider 142 for linear movement incommon with the slider 142. In the illustrated embodiment, the rack 150extends in a direction away from the knob 26, into the more proximalregion of the handle 14. There (as also shown in FIG. 10), the rack 150engages a pinion gear 152. The pinion gear 152 is coupled to a main gear154, which is supported for rotation on a shaft within the handle 14.The main gear 154 is, in turn, coupled through another pinion gear 158to a pick up reel 56, which is likewise supported for rotation on ashaft within the handle 14. The proximal end of the deflecting component30 is coupled to the pick up reel 156. The attachment can beaccomplished, e.g., by crimping, tying, or adhesion.

Rotation of the pick up reel 156 in a predetermined direction (which, inthe illustrated embodiment, is counterclockwise) applies a linear aftpulling force or tension upon the deflecting component 30, therebybending the distal end region of the catheter tube 12.

In an alternative arrangement (not shown), a spiral cut gear coupled tothe knob could engage the rack to move the rack in a linear direction inresponse to rotation of the knob.

As FIG. 11 best shows, the linkage system 28, as described, translatesrotation of the knob 26, which draws the slider 142 toward the knob 26,into linear forward translation of the rack 150. Linear forwardtranslation of the rack 150 is, in turn, translated into rotation of thepinion gear 152 (which, in the illustrated embodiment, is clockwise).Rotation of the pinion gear 152 translates into an opposite rotation(i.e., counterclockwise) of the main gear 154. Rotation of the main gear154 translates into an opposite rotation (i.e., clockwise) of the piniongear 158. Rotation of the pinion gear 158 translates into an oppositerotation (i.e., counterclockwise) of the pick up reel 156. Rotation ofthe pick up reel 156 is, in turn, translated into a linear aft pullingforce or tension on the deflecting component 30, to deflect the distalend of the guide tube 12.

The gear ratio of the rack 150 and the main gear 154, as well as thediameter of the main gear 154, are selected, taking into account thesize constraints imposed by the handle 14, to provide a desiredmechanical advantage. The mechanical advantage amplifies the incrementalamount of deflection of the deflection component 30 for a givenincrement of rotation of the knob 26. Due to the mechanical advantage,the amount of manual, thumb-applied force required to rotate the knob 26is, to the clinician, normal and without strain. Deflection of the guidetube 14 occurs with comfortable thumb control.

b. Pivot Tensioning System

FIGS. 12 and 13 show an alternative arrangement for the steeringassembly 24. The alternative arrangement shown in FIGS. 12 and 13 sharesmany of the functional components of the arrangement shown in FIG. 8.Both include the rotary actuator knob 26 that carries the internalfemale threaded shaft 140, and a slider 142 that carries the threadedmale component 146, which threadably engages the threaded shaft 140.

Also as before described, and as shown in FIG. 13, rotation of theactuator knob 26 is translated into linear movement of the slider 142within the channel 144 inside the handle 14. In the rack and pinionlinkage arrangement shown in FIG. 11, distal movement of the slider 144(toward the knob 26) serves to apply tension to the deflecting component30 through the rotation imparted to the take up reel 156 by the lateralmovement of the rack 150 attached to the slider 144. In the alternativearrangement shown in FIGS. 12 and 13, proximal movement of the slider142 (away from the knob 26) applies tension to the deflection component30 through a tension arm 160 that pivots in a proximal direction alongthe longitudinal axis of the handle 14. The deflecting component 30 isattached to the pivoting tension arm 160 and is placed into tension as aresult of the proximal pivoting movement, to bend the distal region ofthe catheter tube 12, as FIG. 13 shows.

More particularly, the tension arm 160 is mounted on a pin 162 withinthe housing 14 for pivoting between a first pivot position, leaningdistally toward the knob 26 (see FIG. 12) and a second pivot positionleaning proximally away from the knob 26 (see FIG. 13). In the firstpivot position (FIG. 12), no tension is applied to the deflectingcomponent 30 attached to the tension arm 160. In the second pivotposition (FIG. 13), the deflecting component 30 is placed into tension,to bend or deflect the distal end region of the guide tube 12.

When in the first pivot position (FIG. 12), the pivoting tension arm 160rests against the proximal end of the slider 142. As the knob 26 isrotated in a predetermined direction (which, in the illustratedembodiment (FIG. 13), is counterclockwise from the standpoint of theclinician), the slider 142 is moved in a linear direction away from theknob 26. The slider 142 pushes against the tension arm 160, causing itto pivot about the pin 162 into the second pivot position. Pivoting ofthe tension element translates into a linear proximal pulling force ortension on the deflecting component 30, to deflect the distal end of theguide tube 12.

Translating the linear movement of the slider 142 into rotationalmovement of the pivoting tension arm 160 reduces the mechanical forceadvantage of the overall system, while increasing the amount ofdeflection of the distal end region per given rotation of the rotarycontrol element.

3. The Deflection Component

The deflecting component 30 extends from the pick up reel 156 orpivoting tension arm 160 end into the control lumen 34 of the guide tube12. The deflecting component 30 desirably comprises a strong andflexible material, e.g., metallic wire, braided metallic wire,monofilament wire, etc. In a preferred arrangement, the deflectingelement 30 comprises a continuous length of braided polymer or naturalfiber. The fiber extends from the pick up reel 156 or pivoting tensionarm 160, through the control lumen 34, looping completely around the tipreinforcing element 40, as FIG. 6B best shows. From there, the fiberextends back through the control lumen 34 to terminate at the pick upreel 156 or pivoting tension arm 160.

In this arrangement, the deflecting conponent 30 can be attached to thetip reinforcing element 40 by various methods, such as adhesion, weldingtechniques, soldering techniques, tying or wrapping the deflectioncomponent 30 to the tip reinforcing element 40, or by forming thedeflecting component 30 and the tip reinforcing element 40 as acomposite structure. In the alternative embodiment shown in FIG. 6C,separate attachment means may not be necessary to connect the deflectingcomponent 30 to the tip reinforcing element 41.

II. Use of Steerable Guide Device

FIG. 14 shows the steerable guide device 10 in use to guide an operativetool 16 to a tissue site. In FIG. 14, the operative tool 16 takes theform of a powered device that applies a helical fastener 164. Arepresentative embodiment of an endovascular device that, in use,applies a helical fastener is described in U.S. patent application Ser.No. 10/786,465, and entitled “Systems and Methods for Attaching aProsthesis Within a Body Lumen or Hollow Organ,” which is incorporatedherein by reference. In use (as FIG. 14 shows), the endovascularfastener device 16 is manipulated through the guide device 10 to applyone or more fasteners 164 to a prosthesis 166 that is deployed to repairdiseased and/or damaged sections of a hollow body organ and/or a bloodvessel, e.g., to repair an aneurysm in the aorta in the region betweenthe heart and the iliac bifurcation.

In use, the steerable guide device 10 is introduced to the targetedtissue site through a conventional intravascular approach. For example,when the targeted tissue site is in the aorta, the guide device 10 canbe introduced through the femoral artery. However, other access sitesand methods can be utilized. The guide device 10 is desirably introducedover a guide wire, which extends through the passage 18. The guide wirecan comprise the same guide wire over which the prosthesis 166 has beenpreviously introduced, by means of a separately deployed prosthesisintroducing tool. Or alternatively, introduction of the steerable guidedevice 10 can be accomplished through a separate access site.

Upon withdrawal of the prosthesis introducing tool over the guide wire,and under fluoroscopic visualization, the clinician tracks the guidedevice 10 and dilator 60 over the same guide wire to locate the distalend region of the device 10 at or near the desired location with respectto the prosthesis. The guide wire and dilator 60 can now be withdrawn.Actuating the steering assembly 24 (by rotating the knob 26), and stillemploying fluoroscopy visualization, the clinician deflects the distalend region of the device 10—and rotates the handle 14 to rotate thecatheter tube 12, if necessary—to orient the distal opening 22 of thepassage 18 in a desired facing relationship with the site whereintroduction of a fastener 164 is desired.

The operative tool 16, e.g., the endovascular fastener device, is nowinserted through the proximal opening 20 and advanced through thepassage 18 until the fastener 164 is located for deployment outside; thenow-oriented distal opening 23, as FIG. 14 shows. The operative tool 16can be actuated to apply a fastener 164 to the prosthesis 166. If theoperative tool 16 is a singles fire device, i.e., it carries only onefastener 164, the operative tool 16 is withdrawn through the passage 18and a new fastener 164 mounted. The distal end region of the device 10is reoriented in facing relationship with a new fastening site. Theoperative tool 16 is inserted back through the passage 18 to apply thesecond fastener to the new fastening site. This sequence is repeateduntil a desired number and array of fasteners 164 are applied to theprosthesis 166. At this point, the guide device 10 can be withdrawn.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

I claim:
 1. A guide device comprising: a flexible guide tube comprising a main lumen defining a guide passage and at least one control lumen separate from the main lumen, the guide tube further comprising a tip reinforcing element comprising a uniform ring; a handle coupled to the guide tube, the handle comprising a proximal opening in communication with the guide passage through which a separate operative tool can be advanced; and a steering assembly comprising: a deflecting element at least partially within the control lumen and coupled to a distal end region of the flexible guide tube to apply a deflecting force to bend the distal end region, the deflecting element making a continuous loop completely around the tip reinforcing element, an actuator configured to rotate about the longitudinal axis of the guide device and rotatable by a single-handed operation, and a linkage system coupling the actuator to the deflecting element to apply the deflecting force in response to operation of the actuator, the linkage system including a slider and a pivoting lever arm, the slider having a threaded portion adapted to mate with a threaded portion of the actuator, the pivoting lever arm directly coupled to a proximal end of the deflecting element at a first end portion and pivotally attached to the handle at a second end portion and adapted to be contacted by the slider to translate rotation of the actuator into linear movement of the slider into pivotal movement of the lever arm to apply the deflecting force to the deflecting component, wherein the linkage system is positioned within the handle and amplifies the amount of deflecting force.
 2. The device according to claim 1 further comprising at least one additional deflecting element.
 3. The guide device according to claim 1 further comprising at least two control lumens.
 4. The guide device according to claim 3 wherein the control lumens are oriented 180 degrees apart.
 5. The guide device according to claim 1 wherein the distal end region of the guide tube comprises radiopaque markers.
 6. A system comprising: a guide device as defined in claim 1, and an operative tool that applies one or more fasteners to tissue.
 7. A method comprising: providing a guide device as defined in claim 1, deploying the guide device into an interior tissue region, and operating the steering assembly to bend the distal end region of the guide tube.
 8. A method comprising: providing a system as defined in claim 6, deploying the guide device into an interior tissue region, operating the steering assembly to bend the distal end region of the guide tube, passing the operative tool through the guide device, and operating the operative tool while residing in the guide device to apply at least one fastener to tissue. 